Cimetidine 400mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Cimetidine

Предлага се от:

Medreich Plc

АТС код:

A02BA01

INN (Международно Name):

Cimetidine

дозиране:

400mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 01030100; GTIN: 05060292740423

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
CIMETIDINE 200 MG, 400 MG & 800 MG TABLETS
(CIMETIDINE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.
•
If any of the side effects get serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
WHAT CIMETIDINE TABLETS ARE AND WHAT THEY ARE USED FOR
2.
BEFORE YOU TAKE CIMETIDINE TABLETS
3.
HOW TO TAKE CIMETIDINE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CIMETIDINE TABLETS
6.
FURTHER INFORMATION
1.
WHAT CIMETIDINE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Cimetidine Tablets. It contains the
active
ingredient called Cimetidine.
Cimetidine belongs to a group of medicines called H
2
- antagonists.
It works by preventing your stomach from producing too much acid.
The tablets are used to:
• Treat and prevent ulcers in your stomach and the first part of
your
small intestine;
• Prevent acid coming up your throat;
• Prevent your stomach from producing too much acid which could
cause
pain and discomfort, such as heartburn, indigestion or dyspepsia;
• Prevent acid coming up from the stomach during childbirth;
• Prevent ulcers caused by stress;
• Prevent bleeding from ulcers.
• Prior to general anaesthetic in patients at risk from stomach acid
being
sucked into the air passages (Mendelson’s Syndrome), particularly
pregnant patients during labour.
• to reduce malabsorption and fluid loss in short bowel syndrome.
You should ask your doctor if you are unsure why you have been given
Cimetidine Tablets.
2. BEFORE YOU TAKE CIMETIDINE TABLETS
DO NOT TAKE CIMETIDINE TABLETS IF YOU:
•
have an allergy to cimetidine, or any of the other ingredients listed
at the
end of this leaflet.
YO

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cimetidine 400mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cimetidine tablets contain 400 mg of the active ingredient Cimetidine
USP
3
PHARMACEUTICAL FORM
Tablet.
Cimetidine 400 mg Tablets are green capsule shaped film coated tablets
coded
CIM on one side and 400 on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cimetidine is a histamine H2-receptor antagonist which rapidly
inhibits both basal
and stimulated gastric secretion of acid and reduces pepsin output.
Cimetidine is indicated in the treatment duodenal and benign gastric
ulceration
including that associated with non-steroidal inflammatory agents
recurrent and stomal
ulceration, oesophageal reflux disease and other conditions where
reduction of
gastric acid by Cimetidine has been shown to be beneficial: persistent
dyspeptic
symptoms with or without ulceration, particularly meal-related upper
abdominal pain,
including such symptoms associated with non-steroidal
anti-inflammatory agents; the
prophylaxis of gastro-intestinal haemorrhage from stress ulceration in
seriously ill
patients; before general anaesthesia in patients thought to be at risk
of acid aspiration
(Mendelson’s) syndrome, particularly obstetric patients during
labour; to reduce
malabsorption and fluid loss in the short bowel syndrome; and in
pancreatic
insufficiency to reduce degradation of enzyme supplements. Cimetidine
is also
recommended in the management of the Zollinger-Ellison syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The total daily dose should not normally exceed 2.4g. Dosage should be
reduced in
patients with impaired renal function (see section 4.4).
Adults:
The usual dosage is 400 mg twice a day with breakfast and at bedtime.
Alternatively
for patients with duodenal or benign gastric ulceration, a single
daily dose of 800 mg
at bedtime can be used. Other effective regimens are 200 mg three
times a day with
meals and 400 mg at bedtime (1.0 g/day) and, if inadequate, 400mg four
times a